MDR 2017/745 GSPR template

10,00

EU MDR GSPR Checklist. This document is mandatory for the evaluation of the conformity of your Medical Device per MDR 2017/745 Annex I.

The checklist will review all the elements to prove to a Notified Body that you are compliant.

This is needed for all class of products:

  • Custom-made
  • Drug product with a Medical Device
  • Class I
  • Class Ir
  • Class Is
  • Class Im
  • Class IIa
  • Class IIb
  • Class III
Category:

GSPR stands for General Safety and Performance Requirements. This is a checklist that you should provide for proving the compliance to MDR 2017/745.

Previously with MDD 93/42/EC, this was named as Essential Requirements. 

The template will provide you the minimum information you should have on your technical file and will give you some examples of what you should fill on it. In the case of questions you can still reach out by email.

After Download this product is not subject for reimbursement.

GSPR MDR 2017/745 Template

GSPR Template Structure

Product Identification

The first section of the template will help you to identify the scope of the GSPR. Which products are included on the scope and to which technical file it is linked.

Method for evidence

Then, you should list all the elements that you will use to prove evidence to the requirements. This list can contain, standards, regulations, legislation or reference to internal documents or methods.

GSPR list

Finally, there will be the last section with the GSPR checklist. Each of the line should be reviewed and and justification for its compliance should be provided. If this is not applicable you also need to provide some evidence.

After purchasing this product you will receive a Word document that is editable.
If you have any question, don't hesitate to contact us.

Reviews

There are no reviews yet.

Only logged in customers who have purchased this product may leave a review.